FDA 483 - Yung Shin Pharmaceutical Industry Co., Ltd. - October 22, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Yung Shin Pharmaceutical Industry Co., Ltd. in Tachia, Taichung, Taiwan, was inspected and cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed issues with process control monitoring, adherence to cleaning procedures, aseptic processing, disinfectant efficacy, laboratory controls, and incomplete master production records. These observations indicate a lack of robust quality systems necessary to ensure drug product quality and sterility.
ID · ef7b4f8a-8ae0-4e34-97f5-460bf50e6f2b